Recall Z-2380-2010 ยท LGZ Warmer, Thermal, Infusion Fluid
Vital Signs Inc
Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.
| Date | Sep 3, 2010 (initiated Jul 15, 2010) |
| Status | Terminated |
| Reason | The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings. |
| Root cause | Equipment maintenance |
| Action | GE Healthcare issued an "Urgent Medical Device Correction" letter, dated July 15, 2010, to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and quarantine the affected devices, and contact Vital Signs Inc. Customer Service to arrange for return and replacement of the affected devices. Consignees were instructed to complete and return the Confirmation Form. Consignees can contact Vital Signs Inc. Customer Service at 1-973-956-5300 . |
| Quantity | 385,820 domestic - 20,776 international |
| Distribution | Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060537 | EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 Enginivity, LLC, Jun 8, 2006 |